| Date Initiated by Firm | April 19, 2022 |
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| Create Date | June 28, 2022 |
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| Recall Status1 |
Terminated 3 on March 27, 2024 |
| Recall Number | Z-1298-2022 |
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| Recall Event ID |
90358 |
| 510(K)Number | K002177 K041502 |
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| Product Classification |
System, multipurpose for in vitro coagulation studies - Product Code JPA
|
| Product | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -
PlateletMapping ADP & AA (07-014),
PlateletMapping ADP (07-015),
PlateletMapping AA (07-016).
Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1) |
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| Code Information |
This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014, 07-015, 07-016) is performed on a TEG 5000 analyzer (Item # 07-022, 07-033) that is connected to TEG Manager Software which includes viewing of TEG 5000 results.
Code Info: UDI-DI: (01)30812747018184
Software Version: TEGM 1.1 and later, TAS v4.2.3 |
| FEI Number |
1219343
|
Recalling Firm/
Manufacturer |
Haemonetics Corporation
125 Summer St
Boston MA 02110-1616
|
| For Additional Information Contact | Customer Support, Haemonetics
800-537-2802 |
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Manufacturer Reason
for Recall | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays. |
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FDA Determined
Cause 2 | Software design |
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| Action | On April 22, 2022, the firm notified affected customers of the recall via email.
Customers were asked to complete and return the attached acknowledgement form. Upon receipt, Haemonetics will contact the customer to arrange the remote installation of the updated software, version 4.4.0, which will resolve the issue. |
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| Quantity in Commerce | 111 |
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| Distribution | US Nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = JPA
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