Spore Test Monitoring System Printing Error May Cause Result Misdirection
HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall involving a printing error that may cause sterilization test results to be reported to the incorrect customer account in a safety-critical monitoring system. This constitutes a risk-of-harm product defect where no illnesses or injuries have been reported, per the rubric ceiling of 3 for theoretical hazards with no reported harm.
Plain-English summary
HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (Items 1003600 and 1003580). These are spore test monitoring systems designed for sterilization process verification.
The recall was issued due to a printing error on the return envelope. This error may cause spore test results to be reported to the incorrect customer's account.
The recall affects 4,021 units distributed across the United States. Multiple lot codes were affected, with expiration dates ranging from November 30, 2024 to April 30, 2026.
The recalled product
- Product
- Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
- Manufacturer
- HF Acquisition Co LLC
- Affected units
- 4,021
Distribution
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