Z-0136-06

Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512

Name: Z-0136-06 Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
Creator: Nichols Institute Diagnostics
Published: 2005-09-30
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-09-30 / Terminated / root cause: labeling and UDI

FDA source

Nichols Institute Diagnostics began a recall of Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512 on 2005-09-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0136-06
Status: Terminated
Initiated: 2005-09-30
Posted: 2005-11-15
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
Product code: GGT Assay, Erythropoietin
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 215
Distribution: CA, IN, WA
Product codes and lots: Kit lots# 63-502081, 63-502081A contain Calibration Verifiers 1, 2, and 3. Lot #30-500952 is specific to Calibration Verifier 2; Lot #30-500953 is specific to Calibration Verifier 3.

Product code GGT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)