Z-2578-2023Class II

ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for...

Name: Z-2578-2023 ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for...
Creator: Instrumentation Laboratory
Published: 2023-07-13
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2023-07-13 / Open, Classified

FDA source

Instrumentation Laboratory began a recall of ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the... on 2023-07-13. FDA classified it as Class II and gives the reason as "Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2578-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-13
Posted: 2023-09-12
Recalling firm: Instrumentation Laboratory Co.
Product: ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
FDA root cause: Under Investigation by firm
Action: UPDATE: 10/16/23: Update relates to additional ACL TOP Family 50 Series instruments that were installed after the field notification was initiated (Phase I), but prior to inclusion of the notification instructions in start-up kits with new production. During the Installation process, Service field representatives will provide the titled Important Instruction, to the customer. The letter states the same instructions as provided in the Urgent Medical Device Correction Letter initially issued. __________________________________________________________________________ Werfen Issued Urgent Medical Device Correction Letter and Mandatory response tracking form on July 13th, 2023 via email or Certified Mail. Letter states reason for recall, health risk and action to take: Based on the above please take one of the following immediate workflows to mitigate this issue. To avoid the potential sample misidentification, users should not change any samples in the sample rack that have been properly identified. If the user decides they must remove a sample from a sample rack that has been properly identified by the ACL TOP Family 50 Series Instrument, they may do so only after the bar code reader has returned to the home position or the samples have been completely resulted. Alternatively, a user may remove a properly identified sample from a sample rack and must leave that sample rack position empty. x Share this information with your laboratory staff and update your internal procedures, as needed. x Forward this notification to all affected locations in your facility. x Post this notification on all affected systems in your facility. x Retain a copy of this notification for your records. x Complete and return the Mandatory Response Tracking Form to acknowledge the above actions. x Mandatory Response Tracking Record x Return the completed and signed Mandatory Response Tracking Form to: x Fax No.: 1-781-861-4207 Or E-mail: [email protected] x Contact Information for
Quantity in commerce: 2,068 kits US: 6,270 units OUS
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
Product codes and lots: Model Names UDI (1)ACL TOP 550 CTS 08426950729242; (2)ACL TOP 750 CTS 08426950784067; (3)ACL TOP 350 CTS 08426950784081; (4) ACL TOP 750 08426950784074; (5) ACL TOP 750 LAS 08426950784050 (6) ACL TOP 970 CL 08430793045476 Software: 1)ACL TOP 550 CTS v6.3.0 or later; (2)ACL TOP 750 CTS v6.3.0 or later; (3)ACL TOP 350 CTS v6.3.0 or later; (4) ACL TOP 750 v6.3.0 or later; (5) ACL TOP 750 LAS v6.3.0 or later; (6) ACL TOP 970 CL Version 1.1.0 (OUS). UPDATE: 10/16/23 Affected Serial Number Range Start SN End SN ACL TOP 350 CTS 21113058 23074369; ACL TOP 550 CTS 21112046 23072623; ACL TOP 750 22010516 23060671; ACL TOP 750 CTS 21110860 23071015; ACL TOP 750 LAS 21120879 23071077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2578-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2578-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-12

Product code GKP

K150877Class IIAcl Top Family 50 Series: Acl Top 350 Cts; Acl Top 550 Cts; Acl Top 750; Acl Top 750 Cts; Acl Top 750 LasInstrumentation Laboratory CO / cleared 2015-12-13

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)