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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89894

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Instrumentation Laboratory

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

ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097

Z-1014-2022
Recall number
Z-1014-2022
Initiated
February 22, 2022
Classification
Class II
Status
Ongoing
Quantity
2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe

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

Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe

Code information

All Serial Numbers. Trade Name Part Number UDI ACL TOP 300 CTS 00000280060 08426950556916; "ACL TOP 300 CTS (Refurbished)" 00000280060R 08426950928027; ACL TOP 350 CTS 00000280065 08426950784081; ACL TOP 500 CTS 00000280040 08426950453499; "ACL TOP 500 CTS (Refurbished)" 00000280040R 08426950928003; ACL TOP 550 CTS 00000280045 08426950729242; ACL TOP 970 CL 00000280097 08430793045476.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, S. Tome, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad, Tobago, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam.