FDA Recall
Terminated
Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
Recall: Z-0136-06
·
Initiated September 30, 2005
Recall
- Recall Number
- Z-0136-06
- Event Number
- 33774
- Firm
- Nichols Institute Diagnostics
- FEI Number
- 2050095
- Product Code
- GGT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 30, 2005
- Posted
- November 15, 2005
- Terminated
- March 16, 2012
- Address
- 1311 Calle Batido, San Clemente, CA, 92673-6316
Description
Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
Reason
Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2.
Action
Written notification was sent via fax on 9/29/05. If receipt was not confirmed, written version of notification was mailed via next day delivery. NID intends to track the response forms and if after 2 weeks after distribution not all forms have been received, NID will conduct a follow-up phone call and resend if necessary.
Distribution
CA, IN, WA
Quantity
215