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Terminated

ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.

FDA Recall Z-0398-06 · Posted 2006-01-18

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2005-12-08
Date Terminated2007-09-25
Product Quantity1206 units.

Reason for Recall

System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.

Firm Action

Firm initiated recall to all consignees via letter dated 12/08/05.

Root Cause

Other

Distribution Pattern

Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentina, Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Grand Cayman, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Puerto Rico, Singapore, Thailand, Trinidad, Uruquay and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

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

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