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Terminated

Nichols IRMA Intact PTH Assay, catalog No. 40-2171

FDA Recall Z-0809-05 · Posted 2005-05-10

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeCEW
Date Initiated2005-03-25
Date Terminated2012-03-16
Product QuantityNot divulged

Reason for Recall

Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

Firm Action

Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861797ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAYNichols Institute Diagnostics · 1986-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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