Recall Z-1141-2025 ยท FRC Indicator, Biological Sterilization Process
HF Acquisition Co LLC
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
| Date | Feb 11, 2025 (initiated Dec 11, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | On 12/11/2024, correction notices were mailed to customers asking them to do the following: 1. Check the box number on your Biological Weekly Monitoring kit for the affected lot numbers. The box number is located under the bar code on the outside of the box (see image below). 3. Check the serial number on all test strip return envelopes located in the box. This number is the last set of digits in the alphanumeric string located to the left of the bar code on the envelope. 4. Verify that the box number matches the last three digits of the serial number on the return envelope. 5. If the numbers |
| 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 |
| FDA record | Open on fda.gov |