Reported Nov 29, 2017 · Completed

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical…

Abbott Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313

Is this the product you have?

  • ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Lot codes and dates
    • c400073
    • c400103
    • c400498
    • c400600
    • c400890
    • c400934
    • c400935
    • c401018
    • c401055
    • c401056
    • c401182
    • c401505
    • c401520
    • c401686
    • c401887
    • c460196
    • c460200
    • c460943
    • c461550
    • c803669
    • c803753
    • c1600144
    • c1600249
    • c1600251
    • c1600641
    • c1600720
    • c1600819
    • c1600859
    • c1600976
    • c1601350
    • c1601351
Amount recalled
34 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.