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Terminated

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

FDA Recall Z-0648-03 · Posted 2003-03-13

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2002-10-16
Date Terminated2003-08-21
Product Quantity1383 units

Reason for Recall

Product elicits fluorescent signal interference due to contamination.

Firm Action

On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Root Cause

Other

Distribution Pattern

Nationwide and Argentina, Canada and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010953CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAYAbbott Laboratories · 2001-06-06K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYAbbott Laboratories · 1998-06-29K971152ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)Abbott Laboratories · 1997-08-12K961439ABBOTT CELL-DYN 4000 SYSTEMAbbott Diagnostics · 1996-10-18

Official Source

View FDA Recall →

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

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