Z-1014-2022Class II

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...

Name: Z-1014-2022 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...
Creator: Instrumentation Laboratory
Published: 2022-02-22
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2022-02-22 / Open, Classified

FDA source

Instrumentation Laboratory began a recall of 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... on 2022-02-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1014-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-22
Posted: 2022-04-28
Recalling firm: Instrumentation Laboratory Co.
Product: 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
Product code: GKP Instrument, Coagulation, Automated
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
FDA root cause: Under Investigation by firm
Action: *****UPDATE******PHASE 2 UPDATED - URGENT MEDICAL DEVICE CORRECTION This updated notification is intended to further clarify the Mandatory Customer Actions for the potential carryover issue identified on the following ACL TOP systems (previous URGENT MEDICAL DEVICE CORRECTION letter dated Feb 22, 2022), when running a specific reagent combination. E-mail communication to the Werfen Affiliate and International Group circulated on July 14, 2022. Subsequent investigations have shown that the carryover issue only has the possibility of occurring if QFA Fibrinogen, Liquid Antithrombin, and Liquid Anti-Xa reagent aspirations occur in a specific sequence. " Based on the above, we are revising the instruction to not run HemosIL Liquid Anti-Xa in the same batch as both HemosIL Liquid Antiithrombin and HemosIL Q.F.A. Thrombin (Bovine). Please take one of the following immediate workflows to mitigate this potential carryover issue. " Revised Instructions for Phase 2: 1. Use Separate instruments to run Liquid Anti-Xa and Liquid Antithrombin. 2. Batch Liquid Antithrombin.: Run Liquid Antithrombin tests in isolation (analyzer status starting and ending in a READY state). 3. Batch Anti-Xa, Apixaban and Rivaroxaban testing. Run the maintenance activity Enhanced Clean for Reagent Probe or Enhanced Clean for All Probes from the maintenance menu, then run Liquid Anti-Xa (heparin), apixaban, and rivaroxaban tests in isolation (analyzer status starting and ending in a READY state). Return the completed and signed Mandatory Response Tracking Form to: " Fax No.: 1-781-861-4207 Or E-mail: [email protected] For technical questions, please contact the Werfen Technical Support Center at 1-800-678-0710, Option # 1 (ACL Coagulation Products). Previous: PHASE 1: Werfen issued Urgent Field Safety Notification via email /certified mail on 2/22/22. Letter states reason for recall, health risk and action to take: Mandatory Customer Actions Based on the above, please take the following i
Quantity in commerce: 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1014-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-28

Product code GKP

K160276Class IIAcl Top (Acl Top 700, Acl Top 700 Cts, Acl Top 700 Las, Acl Top 500 Cts, Acl Top 300 Cts)Instrumentation Laboratory CO / cleared 2016-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)