Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Recall
- Recall Number
- Z-0290-2018
- Event Number
- 78728
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- GNB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 8, 2017
- Terminated
- July 22, 2020
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
The serum may fail to agglutinate within the specified minimum reaction time.
The recalling firm issued letters dated 12/8/2017 via regular mail. The letter identified the affected product, problem and actions to be taken. The risk to health is also explained. The customer is requested to notify any personnel who need to be aware of the potential for incorrect performance specification for the product. The customer is to inspect their stock and destroy any remaining inventory of the lots listed. They are to contact Customer Service or their local distributor for replacement. A response form was to be returned acknowledging receipt of the notice and disposal of the affected product. If the product was further distributed, the customer was requested to contact their downstream customers, advise them of the recall, and provide them a copy of the recall letter.
US Nationwide Distribution
237 units (single bottles)