RegWardenFDA facility compliance records
Facility

Haemonetics Mexico Manufacturing S. de R.L. de C.V.

8 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2022: 2 recalls1’13’141’15’161’171’181’191’20’212’22’23’24’25’26
  • Recalls (8)

Devices registered here (1)

  • Separator, Automated, Blood Cell, Diagnostic
    Product code GKT (opens in a new tab) · Class II · Hematology · 21 CFR 864.9245

Recalls & enforcement

  • Class IITerminated2022-04-26
    Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or …
  • Class IITerminated2022-04-19
    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.
  • Class IITerminated2020-02-19
    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 displayi…
  • Class IITerminated2019-10-21
    Potential to develop leaks at the inner core of Cell Saver® 5/5+ and Cell Saver® Elite®/Elite® +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
  • Class IITerminated2018-07-13
    OrthoPAT® reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
  • Class IITerminated2017-08-02
    Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
  • Class IITerminated2015-01-26
    Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
  • Class IITerminated2013-06-20
    Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Haemonetics Mexico Manufacturing S. de R.L. de C.V. (FEI 3003327833) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003327833-haemonetics-mexico-manufacturing-s-de-r-/

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