API 50CH
Brand(s)
Summary
| Contact the manufacturer if you require additional information. |
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| API 50CH | 1008603700 | Not applicable. |
Issue
|
During the internal investigation of the non-conformance opened on API 50 CH sequence 40-49 lots #1008352920 and 1008510240 for false positive results on test 49 it was confirmed that test 19 of API 50 CH lot# 1008603700 contains a mix of sorbitol(SOR) and 5-Ketogluconic acid (5kg, which is contained in the solution of the test 49) instead of sorbitol only. The mix is estimated to represent almost 80% SOR and 20% 5kg. During the investigation it was identified that test well 19 could be impacted on two API 50 CH lots, 1008603700 and 1008511380 and product stop shipment(PSS) was issued for both lots on 22 June 2021. The NMR analysis was performed on well 19 of both API 50 CH lots, this testing confirmed that lot 1008511380 is conforming. Recall date: 2021-08-13 |
Additional information
Details
|
BIOMERIEUX SA, 376, CHEMIN DE L'ORME, MARCY-L'ETOILE France |
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