Recall Z-2057-2014— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2014-06-11, terminated 2014-08-28. It names one FDA 510(k) clearance: K032306. Product: Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.. Reason: Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-11
- Terminated
- 2014-08-28
- Firm location
- Lenexa, KS, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Reason for recall
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Data sourced from openFDA. This site is unofficial and independent of the FDA.