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Terminated

D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.

FDA Recall Z-1314-06 · Posted 2006-08-01

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCGZ
Date Initiated2005-02-01
Date Terminated2011-11-18
Product Quantity85/4 unit boxes

Reason for Recall

The CI membrane units generate too low values for status and sensitivity during calibration.

Firm Action

The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc. · 1998-02-09

Official Source

View FDA Recall →

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

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