FDAClass IIJune 16, 2021

Quickslide GramPro 1 Automated Gram Stanier is a recall

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

Why was Quickslide GramPro 1 Automated Gram Stanier is a recalled?

Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590, 592, 596, 603, 606, 616, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655, 656, 657, 658, 2005,2012

Product
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Recalling firm
Hardy Diagnostics
Quantity
69 units
Distribution
US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.
Recall date
June 16, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls