DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit
FDA device recall Z-1464-2015 · posted 2015-04-20 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
- Action taken
- DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MLM
- Quantity affected
- 451 kits
- Distribution
- Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
- Date initiated
- 2015-03-16
- Date posted
- 2015-04-20
- Date terminated
- 2015-09-15
- Location
- Stillwater, MN
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