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An official Health Canada notice concerns Api 50ch. 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 Published 2021-11-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63552
Official notice
2021-11-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Biomerieux, API 50ch.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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