FDA Device Recall Z-0013-2015: Richard-Allan Scientific Company

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2015.

Recall Res Number

Z-0013-2015

Recalling Firm / Manufacturer

Richard-Allan Scientific Company

FEI Number

1831638

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-17

Date Posted

2014-10-09

Date Terminated

2016-10-27

Product Code

LDY

Event Number

69276

Product Quantity

285 cases

Product Description Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Reason for Recall The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Action Details The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com.

Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Code Information / Serial Numbers Product Code: 534801 Lot Number: 296986

Related Establishments / Registrations

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MICHCLONE ASSOCIATES, INC. Registration: 1831312 View Registration
RICHARD-ALLAN SCIENTIFIC LLC Registration: 1831638 View Registration
Delasco, LLC Registration: 1930126 View Registration
MEDICAL CHEMICAL CORPORATION Registration: 2013736 View Registration
GLOBE SCIENTIFIC, LLC Registration: 2244900 View Registration
Ethos Biosciences, INC. Registration: 2247035 View Registration
VOLUSOL Registration: 3002805583 View Registration
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Apacor Limited Registration: 3003703247 View Registration
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Cancer Diagnostics, Inc. Registration: 3007496191 View Registration
NEWCOMER SUPPLY INC Registration: 3008174888 View Registration
AZER SCIENTIFIC, INC. Registration: 3009963993 View Registration
LABOTEK GROUP CORP Registration: 3010194621 View Registration
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Wuhan Landing Intelligence Medical Co.,Ltd Registration: 3010461097 View Registration
DIAPATH S.P.A. Registration: 3010692993 View Registration
CITOTEST SCIENTIFIC CO.,LTD. Registration: 3015505238 View Registration
SSN SOLUTIONS Registration: 3022312148 View Registration

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Medical Device Recall: Z-0013-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer