Recall Z-0962-2019 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Organon Teknika Inc
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82
| Date | Jan 11, 2019 |
| Status | Terminated |
| Reason | This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards |
| Root cause | Process control |
| Action | The recall was issued to bioMrieux subsidiaries and distributors via email notification on Friday, January 11th, 2019. Impacted customers were notified via correction notice (customer letter) issued on 01/19/2019 from each associated subsidiary/distributor onto local letterhead. The letter directed the user to perform a "tug test" to determine if the product is defective. Defective units were to be discarded and a credit issued. |
| Quantity | 129,321 cartons |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.