ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the ant
FDA device recall Z-2095-2017 · posted 2017-05-03 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- False susceptible results
- Action taken
- bioMerieux sent an Urgent Product Safety Correction Notice on April 25, 2017 to U. S. consignees. The letter requested that they provide the notice to all appropriate personnel in the laboratory, asking them to identify any possible False Susceptible results. The letter included a Acknowledgment Form to be returned. On this notice the consignee will indicate the number of kits discarded. For customers with questions please contact their local bioMerieux Customer Service representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 3,238 units
- Distribution
- NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA
- Date initiated
- 2017-04-25
- Date posted
- 2017-05-03
- Date terminated
- 2022-02-24
- Location
- Marcy L'Etoile, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ETEST ERTAPENEM (K020748) | Ab Biodisk | 2002-04-29 |