Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84140

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 23, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott GmBH & Co. KG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

Z-0575-2020
Recall number
Z-0575-2020
Initiated
October 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Abbott GmBH & Co. KG
Quantity
105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

Code information

REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03

Distribution pattern

Worldwide and US Nationwide in the states of: AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong, INDIA, ITALY, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UAE, and UNITED KINGDOM