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Terminated

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.

FDA Recall Z-0290-2018 · Posted None

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeGNB
Date Initiated2017-12-08
Date Terminated2020-07-22
Product Quantity237 units (single bottles)

Reason for Recall

The serum may fail to agglutinate within the specified minimum reaction time.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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