Z-1617-2020Class II

TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1...

Name: Z-1617-2020 TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1...
Creator: Haemonetics Corporation
Published: 2020-02-19
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2020-02-19 / Terminated / root cause: software

FDA source

Haemonetics Corporation began a recall of TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies on 2020-02-19. FDA classified it as Class II and gives the reason as "Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1617-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-19
Posted: 2020-03-31
Terminated: 2021-06-21
Recalling firm: Haemonetics Corporation
Product: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
Root cause tag: software
FDA root cause: Software design
Action: Haemonetics sent US customers using a TEG 5000 device and TEG Manager software a customer letter via email on February 19, 2020. This customer letter notified end users that Haemonetics is conducting a voluntary correction of all TEG Manager software used in conjunction with the TEG 5000 device. Letter states reason for recall, health risk and action to take: Haemonetics is developing a patch to correct the issue with the TEG Manager software. The patch is expected to be available in March of 2020. Haemonetics will contact customers when the TEG Manager software patch is available for download and we will follow up with each user to ensure that the patch has been received and implemented. In the meantime, customers using TEG Manager with the TEG 5000 device should continue to follow the instructions in the TEG 5000 user manual, which state that, Before making any decisions, the attendant physician must consider all clinical information about the patients condition, the procedure, and previous therapy. Users should rely on the actual value of each test result which is correctly displayed on the TEG 5000 and TEG Manager and should not make clinical decisions based solely on the out of range alerts displayed by TEG Manager software. Recipients of this notice should complete the attached acknowledgement form in its entirety.
Quantity in commerce: 88 units
Distribution: US Nationwide distribution.
Product codes and lots: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0, and 4.1.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code JPA

K002177Class IIThrombelastograph Coagulation Analyzer Teg-5000 SeriesHaemoscope Corp. / cleared 2000-09-14

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)