Remel Inc: Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

Recall number

Z-1401-2019

Recalling firm

Remel Inc

Product

Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

Status

Terminated

Initiated

2019-04-17

Posted

not on file

Terminated

2020-07-10

Reason

Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.

Root cause

Under Investigation by firm

Action

Thermo Fisher Scientific/ Remel notified consignees on about 04/17/2019 via " URGENT MEDICAL DEVICE FIELD ACTION RECALL" letter. Instructions included to locate all affected in inventory, destroy any affected product identified, contact Customer Services or local distributor to arrange for replacements, notify all customers if product was further distributed, and complete and return the Field Action Response form. Customers were also instructed that the requirement for review of reported test results using product beyond the updated expiry date should be determined by the appropriate technical expert at each customer location. Thermo Fisher Scientific/Remel expanded the recall and notified consignees on about 05/08/2019 via "URGENT MEDICAL DEVICE FIELD ACTION RECALL AMENDED NOTICE: ADDITIONAL IMPACTED LOTS" letter. The letter contained the same instructions as the initial letter, but the updated letter provided the additional impacted lots and requested that consignees respond again confirming receipt and understanding of the expansion. Questions or concerns can be directed to Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Quantity

2,263 units

Distribution

Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.

Lot, serial or model codes

Material Number: R064720;   Lot Number (Labeled Expiration Date): 298486 (11/27/2018), 309147 (12/12/2018), 313760 (12/20/2018), 314883 (12/24/2018), 316606 (12/26/2018), 320904 (01/01/2019), 325887 (01/10/2019), 329880 (01/17/2019), 337679 (02/04/2019), 340776 (02/11/2019), 342665 (02/13/2019), 347320 (02/28/2019), 354828 (03/07/2019), 358178 (03/14/2019), 359886 (03/19/2019), 363510 (03/26/2019), 367408 (04/02/2019), 369555 (04/08/2019), 372099 (04/11/2019), 373073 (04/15/2019), 374683 (04/17/2019), 379731 (04/25/2019), 385227 (05/07/2019), 388691 (05/14/2019), 389364 (05/15/2019), 393231 (05/22/2019), 398293 (06/10/2019), 404758 (06/13/2019), 417773 (07/17/2019).

510(k) numbers

not on file

PMA numbers

not on file

Product code

JSG

Firm FEI

1924669

Firm city

Lenexa

Firm state

KS

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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