Biological recall
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests…
Why was Biological recalled?
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item/UDI-DI/Lot(Expiration): 1003600/10850065007820/ 2301060(11/30/2024) 2302261(11/30/2024) 2307261(12/31/2024 2312260(1/31/2025) 2313062(1/31/2025) 2331880(6/30/2025) 2401664(8/31/2025) 2414060(2/28/2026) 2414862(3/31/2026) 2414870(3/31/2026) 2416470(3/31/2026) 2416481(4/30/2026) 2416482(4/30/2026) 1003580/10850065007813/2421181(5/31/2026)
- Product
- Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests…
- Recalling firm
- HF Acquisition Co LLC
- Quantity
- 4,021
- Distribution
- US: WI, FL, NY, CO, NJ, OH, IN, CA, WA, TX, AZ, MD, MN, NC, MI, MS, ID, TN, KS, SC, RI, LA, GA, PA, NH, UT, VA, MA, NV, MO, IL, SD, AR, OR, HI, NE, DC, CT, NM, ND, MT, OK, AL, VT, WY, KY, ME, IA, WV, AK
- Recall date
- February 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)