Advertisement
News
Advertisement

bioMérieux, Inc. Issues Urgent Expanded Product Recall for VITEK® 2 Piperacillin/Tazobactam Test on Gram Negative Susceptibility Cards

Fri, 04/08/2011 - 12:20pm

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

bioMérieux, Inc. Issues Urgent Expanded Product Recall for VITEK® 2

Piperacillin/Tazobactam Test on Gram Negative Susceptibility Cards

 

Contact:

Consumer:

1-800-682-2666 (option 3)

Media:

Allan Mohess

1-919-620-2937

allan.mohess@biomerieux.com 

 

FOR IMMEDIATE RELEASE - April 8, 2011 - As a follow up to the communication issued on September 16, 2010, bioMérieux, Inc. is voluntarily expanding its worldwide product recall of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPBlack circle with a 2 inside). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System. Clinical laboratories have been notified to perform an alternative method of testing prior to reporting results for:

  • Piperacillin/Tazobactam (TZPBlack circle with a 2 inside) and Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa and Salmonella enterica
  • Piperacillin/Tazobactam (TZPBlack circle with a 2 inside) and Klebsiella pneumoniae with resistant results 

     

bioMérieux has provided instructions to its customers informing them that VITEK® 2 susceptibility testing results for TZPBlack circle with a 2 inside for the organisms listed above are potentially inaccurate and should not be reported. An alternative method should be used for testing and reporting Piperacillin/Tazobactam susceptibility. Customers can continue to use the VITEK® 2 Gram Negative Susceptibility cards for other antibiotics and for TZPBlack circle with a 2 inside testing of Acinetobacter baumannii, Citrobacter koseri, Serratia marcescens and Klebsiella pneumoniae with susceptible results.
The previous product correction notification (410874) informed users that due to performance issues, users should test all E. coli strains (regardless of VITEK® 2 results), and Klebsiella pneumoniae with resistance by VITEK® 2 testing by an alternative method prior to reporting susceptibility results. A subsequent internal investigation conducted by bioMérieux determined that VITEK® 2 Gram Negative Susceptibility cards may also incorrectly determine M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P aeruginosa and S. enterica susceptibility such that susceptible isolates may be reported as resistant to Piperacillin/Tazobactam (TZPBlack circle with a 2 inside), and resistant isolates reported as susceptible to Piperacillin/Tazobactam (TZPBlack circle with a 2 inside). The current expanded recall is based on these findings. This investigation also confirmed the previously identified performance issues with E. coli and K. pneumoniae testing.
Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli, M. morganii, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, P. aeruginosa or S. enterica isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible results for Piperacillin/Tazobactam (TZPBlack circle with a 2 inside) and isolates of these specific organisms, or for falsely-resistant K. pneumoniae results.
Included below is a list of VITEK® 2 Gram Negative Susceptibility cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK® 2 Gram Negative Susceptibility cards created that contain TZPBlack circle with a 2 inside are affected by this product correction.
bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.
Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm; or by fax at 1-800-FDA-0178. 
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2010, revenues reached €1.357 billion with 87% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).

Other information can be found at www.biomerieux.com.

List of all currently available test cards that contain TZPBlack circle with a 2 inside
Cards Distributed outside the U.S. only

Card Name

Ref. #

  

Card Name

Ref. #

 

Card Name

Ref. #

AST-N080

22214

 

AST-N117

22290

 

AST-N152

22347

AST-N081

22215

 

AST-N118

22291

 

AST-N153

22348

AST-N082

22217

 

AST-N120

22293

 

AST-N155

22352

AST-N084

22224

 

AST-N121

22295

 

AST-N156

22353

AST-N085

22225

 

AST-N122

22299

 

AST-N157

22354

AST-N086

22234

 

AST-N123

22301

 

AST-N158

22355

AST-N087

22235

 

AST-N124

22303

 

AST-N159

22356

AST-N088

22236

 

AST-N127

22308

 

AST-N160

22357

AST-N089

22237

 

AST-N128

22309

 

AST-N161

410026

AST-N090

22240

 

AST-N129

22310

 

AST-N162

410023

AST-N091

22241

 

AST-N130

22311

 

AST-N163

410084

AST-N093

22243

 

AST-N131

22315

 

AST-N164

410101

AST-N093

22246

 

AST-N132

22316

 

AST-N165

410102

AST-N094

22247

 

AST-N133

22318

 

AST-N166

410136

AST-N095

22249

 

AST-N134

22319

 

AST-N167

410138

AST-N096

22250

 

AST-N135

22322

 

AST-N168

410139

AST-N097

22251

 

AST-N136

22323

 

AST-N170

410222

AST-N098

22253

 

AST-N137

22324

 

AST-N171

410249

AST-N100

22256

 

AST-N138

22326

 

AST-N172

410298

AST-N103

22259

 

AST-N139

22327

 

AST-N174

410404

AST-N104

22261

 

AST-N140

22328

 

AST-N175

410403

AST-N105

22262

 

AST-N141

22329

 

AST-N176

410402

AST-N106

22264

 

AST-N142

22332

 

AST-N177

410392

AST-N107

22265

 

AST-N143

22333

 

AST-N178

410393

AST-N108

22272

 

AST-N144

22334

 

AST-N179

410640

AST-N109

22273

 

AST-N145

22338

 

AST-N180

410771

AST-N110

22274

 

AST-N146

22341

 

AST-N181

410803

AST-N111

22275

 

AST-N147

22342

 

AST-N182

410804

AST-N112

22281

 

AST-N148

22343

 

AST-N183

411021

AST-N114

22283

 

AST-N149

22344

 

AST-N184

411154

AST-N115

22285

 

AST-N150

22345

 

 

 

AST-N116

22289

 

AST-N151

22346

 

 

 

Cards Distributed Globally

(including U.S.)

Card Name

Ref. #

AST-GN22

22227

AST-GN23

22228

AST-GN24

22229

AST-GN25

22230

AST-GN26

22244

AST-GN27

22245

AST-GN28

22254

AST-GN29

22266

AST-GN30

22267

AST-GN31

22268

AST-GN32

22269

AST-GN33

22270

AST-GN34

22271

AST-GN35

22286

AST-GN36

22300

AST-GN37

22312

AST-GN39

22337

AST-GN40

410756

AST-GN41

410757

AST-GN42

410758

AST-GN43

410759

AST-GN44

410805

 

 

##

SOURCE

Topics

Advertisement
Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading