Recall Z-1888-2017— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2017-03-24, terminated 2017-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.. Reason: Confirmed complaint of surface contamination of Listeria monocytogenes..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-24
- Terminated
- 2017-06-06
- Firm location
- Lenexa, KS, United States
Product description
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Reason for recall
Confirmed complaint of surface contamination of Listeria monocytogenes.
Data sourced from openFDA. This site is unofficial and independent of the FDA.