Recall Z-0698-2022

Microbiologics Inc · initiated June 6, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.

Codes / lots: Catalog Number: 8193; Lot Number: 8193-04, 8193-06; UDI: 70845357041080

Reason for recall

Real-time shelf life testing failed at 24 months

FDA-determined cause: Process design

Action taken

Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.

Details

Recall number
Z-0698-2022
Initiated
June 6, 2017
Terminated
January 17, 2023
Product code
OHQ – Multi-Analyte Controls Unassayed
Quantity
29 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Recalling firm
Microbiologics Inc, Saint Cloud, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0697-2022 Class IIMicrobiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification…Real-time shelf life testing failed at 24 months 06/06/2017Terminated
Z-0699-2022 Class IIHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory…Real-time shelf life testing failed at 24 months 06/06/2017Terminated
Z-0700-2022 Class IIHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria…Real-time shelf life testing failed at 24 months 06/06/2017Terminated
Z-0701-2022 Class IIHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and…Real-time shelf life testing failed at 24 months 06/06/2017Terminated