Recalls / —
—#160235
Product
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 product code
- GNB — Antisera, All Types, Shigella Spp.
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bottle lot #1847290; Kit lot #2161363, Bottle lot #1847290; Kit lot #1984639, Bottle lot #1847290; Kit lot #1738564, Bottle lot#1738565; Kit lot #1971308, Bottle lot #1738565; Kit lot #1957305, Bottle lot #1738565; Kit lot #1947930, Bottle lot #1738565; and Kit lot #1847285, Bottle lot #1738565.
Why it was recalled
The serum may fail to agglutinate within the specified minimum reaction time.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2017-12-08
- Terminated
- 2020-07-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.