Class I Medical Device Recall: bioM & #xe9;rieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
Recall Class: I
Date Recall Initiated: September 16, 2010
Product: VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
Affected card names and lot numbers (reference numbers) are listed in the Firm Press release under Useful Links below. See also below for link to product label photo.
All lot numbers currently in distribution, as well as future distribution, are affected until further notice.
These products were manufactured from March 10, 2008 through September 9, 2010 and distributed from March, 2009 through September, 2010.
Use: These cards are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK System.
595 Anglum Rd
Hazelwood, Missouri 63042
Reason for Recall:
VITEK 2 Gram Negative Susceptibility Cards that contain Piperacillin/Tazobactam are reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae to this drug.
For E. coli, both falsely-resistant and falsely-susceptible results have been reported; for K. pneumoniae, only falsely-resistant results have been observed. Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.
Susceptibility results for other antibiotics on the VITEK 2 Gram Negative Susceptibility Cards are unaffected.
- Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day.
- 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 by contacting bioMérieux Customer Service at 1-800-682-2666, option 3, 24 hours a day.
FDA District: Kansas
On September 16, 2010, the company sent all their customers a recall letter by overnight mail (regardless of whether they ever ordered the recalled cards).
The letter explained the reason for recall. The company instructed their customers to modify the VITEK 2 device to not report the results from VITEK 2 testing of E. coli susceptibility to Piperacillin/Tazobactam, and to test E. coli susceptibility to Piperacillin/Tazobactam by an alternative method.
For K. pneumoniae, customers were instructed to modify the VITEK 2 device to not report the results for Piperacillin/Tazobactam resistant bacterial isolates, and to test isolates not reported as susceptible with an alternative method for determining resistance.
These alternative test confirmations are to continue until further notice.
An acknowledgement form was enclosed with the recall letter to indicate that the customer has read the notice, followed the instructions provided in the "Action Required" section and asked if the customers have received any reports of illness or injury related to this recall.
All future shipments of this product will include an orange multi-language insert to go into the boxes reminding customers that they must perform an alternate test for TZP/E.coli combinations and that customers must also perform an alternative method prior to reporting TZP results when a resistant result is obtained for TZP/K. pneumoniae.
This recall letter will accompany shipments of instrument software kits for all new customers.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.