FDA Medical Device Recalls (openFDA)
BioMerieux SA: API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
- Recall number
- Z-0756-2016
- Recalling firm
- BioMerieux SA
- Product
- API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
- Status
- Terminated
- Initiated
- 2016-01-08
- Posted
- 2016-02-04
- Terminated
- 2017-07-14
- Reason
- Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.
- Root cause
- Other
- Action
- BioMrieux sent an Urgent Field Safety Notice letter DATED jANUARY 8, 2015 to affected customers. The letter identified the affected product, problem and action to be taken. dated . The letter indicated that they could continue to use product in inventory with mandatory requirements that before using a ZYM B ampule and each day of use of API strips that they perform a quality control with ATCC strains as described in each package insert of involved API strips. The letter also requested that they distribute this letter to all appropriate personnel in the laboratory, retain a copy for their files, and forward the information to all parties that may use the product. For additional assistance or have any questions, contact your local bioMrieux Customer Service representative.
- Quantity
- 13,271
- Distribution
- Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY
- Lot, serial or model codes
- Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16 Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16 Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16 Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16 Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16 Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16 Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16 Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16 Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIB
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28