- FDA announced two separate Class I recalls, one for test strips used at home with meters that monitor the blood thinner warfarin, and the other for a fluid transfer system that connects a medication vial to an intravenous (IV) therapy bag.
- In the test strip recall, FDA is warning patients and doctors that Roche Diagnostics' test strips, used with CoaguChek meters, may give inaccurate results. The Roche test strips were distributed by Terrific Care/Medex Supply.
- The fluid transfer system recall is for Vial2Bag devices made by West Pharmaceutical Services. The company is voluntarily recalling the devices because they may not adequately transfer concentrated medication from a vial to an IV bag, which could cause an overdose or underdose with life-threatening consequences for the patient, FDA said.
Millions of Americans take the blood thinner warfarin to prevent and treat blood clots. Bristol-Myers Squibb manufacturers the drug under the brand name Coumadin, and Upsher-Smith Laboratories makes a generic version called Jantoven.
In December, medical products distributor Terrific Care/Medex Supply issued a voluntary recall of some Roche Diagnostics test strip lots used with the CoaguChek test meter. The action followed a November 2018 recall by Roche, which makes both the CoaguChek meters and the test strips.
The Roche recall, which is still in effect, included more than 1.1 million packages of CoaguChek XS PT Test Strips distributed from Jan. 12, 2018, to Oct. 29, 2018.
The latest recall of CoaguChek XS PT Test Strips includes catalog numbers not included in the Roche recall because the products were not labeled or authorized for sale in the United States, FDA said. Terrific Care/Medex Supply bought the test strips from an unknown source and imported and sold them in the United States, according to the agency.
The recall affects 759 boxes in the United States with manufacturing dates of October 2017 to May 2018 and distribution dates from Dec. 27, 2017, to Dec. 15, 2018.
Patients and healthcare providers using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and should instead have their blood drawn and warfarin levels measured by a laboratory test or use an alternative meter device, FDA said.
Separately, FDA said West Pharmaceutical Services' recall of the Vial2Bag Direct Connect 13mm and 20mm devices affects 38.8 million units nationwide. FDA said it received 16 complaints of serious adverse health consequences related to the use of the 13mm device with oxytocin in pregnant women in connection with labor and delivery. FDA said all Vial2Bag fluid transfer systems are being recalled while an investigation is conducted.
The Vial2Bag systems under recall were manufactured between Feb. 9, 2016, and Jan. 1, 2019, and distributed from March 15, 2016, to Jan. 8, 2019. The model numbers are 6070104, 6070111, 6070112.
Customers are instructed to immediately discontinue use of the device, remove it from inventory and quarantine the product to prevent inadvertent use.