Tubes, Vials, Systems, Serum Separators, Blood Collection（JKA）

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.

The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.

Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.

Some of the tubes may be incorrectly labeled.

The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.