Recall Z-0290-2018— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2017-12-08, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The serum may fail to agglutinate within the specified minimum reaction time..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-08
- Terminated
- 2020-07-22
- Firm location
- Lenexa, KS, United States
Product 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.
Reason for recall
The serum may fail to agglutinate within the specified minimum reaction time.
Data sourced from openFDA. This site is unofficial and independent of the FDA.