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Acl Top 300 Cts/350 Cts/500 Cts/550 Cts/970 Cl recallZ-1014-2022 · Instrumentation Laboratory · initiated Feb 22, 2022

Class II Open, Classified All recalls posted in April 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Instrumentation Laboratory or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

*****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

Recall details

Recall number
Z-1014-2022
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 22, 2022
Posted by the FDA
Apr 28, 2022
Recalling firm
Instrumentation Laboratory
Quantity
2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
Product code
GKP
FDA submissions
K160276
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 description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K160276 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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